Validation at the speed of AI. Evidence that holds up in an audit.

Validation at the speed of AI. Evidence that holds up in an audit.

Automated GxP computer system validation — qualification scripts, traceability, and audit-ready records generated in a fraction of the time, built to satisfy FDA 21 CFR Part 11 and EU Annex 11.

Automated GxP computer system validation — qualification scripts, traceability, and audit-ready records generated in a fraction of the time, built to satisfy FDA 21 CFR Part 11 and EU Annex 11.

See How It Works

See How It Works

Logo
Logo

The Paradigm Shift

The Paradigm Shift

Stop managing validation. Start executing it.

Stop managing validation. Start executing it.

Legacy tools organise your paperwork. Eventt AI does the work, turning a manual, months-long grind into an automated workflow your team reviews and approves.

Legacy tools organise your paperwork. Eventt AI does the work, turning a manual, months-long grind into an automated workflow your team reviews and approves.

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Before

Validation in Months

Validation in Months

Manual scripts, manual clicks, manual screenshots. Every artifact assembled by hand, every deadline at the mercy of human bandwidth.

Manual scripts, manual clicks, manual screenshots. Every artifact assembled by hand, every deadline at the mercy of human bandwidth.

Spreadsheets

Spreadsheets

Hand-written test scripts

Hand-written test scripts

Word protocols

Word protocols

Templates everywhere

Templates everywhere

Screenshot folders

Screenshot folders

Evidence captured manually

Evidence captured manually

Eventt AI

The complete validation engine

After

Validation in Days

AI reads your requirements, runs the tests, captures the evidence, and assembles the package. Your team reviews and approves.

After

Validation in Days

AI reads your requirements, runs the tests, captures the evidence, and assembles the package. Your team reviews and approves.

Eventt AI

The complete validation engine

Eventt AI

The complete validation engine

After

Validation in Days

AI reads your requirements, runs the tests, captures the evidence, and assembles the package. Your team reviews and approves.

How It Works

How It Works

From requirement to review-ready evidence, automatically.

From requirement to review-ready evidence, automatically.

Eventt AI generates, executes, and documents. Your team reviews and approves.

Eventt AI generates, executes, and documents. Your team reviews and approves.

URS-014

User Requirement Spec

Ingested

URS-014

User Requirement Spec

Ingested

Step 1

AI test script generation

Ingest your requirements and instantly generate risk-based test scripts.

QMS · UAT-02

Batch record

BR-2219 · Line 4

Reviewed by QA

Approve record

Step 2

Autonomous Execution

The AI acts as the tester, driving your configured system, logging defects, and capturing time-stamped screenshots.

QMS · UAT-02

Batch record

BR-2219 · Line 4

Reviewed by QA

Approve record

Requirement

URS-014

Test case

URS-014

Evidence

URS-014

Step 3

Audit-Ready Traceability

Every executed step is cross-referenced to its requirement and evidence, then assembled into a validation package for review.

Requirement

URS-014

Test case

URS-014

Evidence

URS-014

ROI / Benefits

ROI / Benefits

Built for speed. Designed for the auditor.

Built for speed. Designed for the auditor.

Reclaim the hours your experts lose to repetitive execution, without cutting a single compliance corner.

Reclaim the hours your experts lose to repetitive execution, without cutting a single compliance corner.

Accelerate Timelines

Compress a manual validation cycle from months of hand-execution into a fraction of the time.

With Eventt AI

Weeks

Manual workflow

Months

Design out human error

A complete, consistent evidence trail every time, captured automatically, time-stamped, and tamper-evident.

Evidence Trail

OQ-2214

Log in as QA-02

0.4s

Apply e-signature

0.3s

Capture audit entry

0.6s

Zero discrepancies

14:32:07 UTC

Empower Your Experts

Free your highly-skilled QA and CSV teams to focus on quality strategy instead of repetitive grunt work.

Quality Experts

Empower Your Experts

Free your highly-skilled QA and CSV teams to focus on quality strategy instead of repetitive grunt work.

Quality Experts

Empower Your Experts

Free your highly-skilled QA and CSV teams to focus on quality strategy instead of repetitive grunt work.

Quality Experts

Design out human error

A complete, consistent evidence trail every time, captured automatically, time-stamped, and tamper-evident.

Evidence Trail

OQ-2214

Log in as QA-02

0.4s

Apply e-signature

0.3s

Capture audit entry

0.6s

Zero discrepancies

14:32:07 UTC

Accelerate Timelines

Compress a manual validation cycle from months of hand-execution into a fraction of the time.

With Eventt AI

Weeks

Manual workflow

Months

Accelerate Timelines

Compress a manual validation cycle from months of hand-execution into a fraction of the time.

With Eventt AI

Weeks

Manual workflow

Months

Design out human error

A complete, consistent evidence trail every time, captured automatically, time-stamped, and tamper-evident.

Evidence Trail

OQ-2214

Log in as QA-02

0.4s

Apply e-signature

0.3s

Capture audit entry

0.6s

Zero discrepancies

14:32:07 UTC

Empower Your Experts

Free your highly-skilled QA and CSV teams to focus on quality strategy instead of repetitive grunt work.

Quality Experts

Empower Your Experts

Free your highly-skilled QA and CSV teams to focus on quality strategy instead of repetitive grunt work.

Quality Experts

GxP by Design

GxP by Design

Compliance controls, built in from the start.

Compliance controls, built in from the start.

Eventt AI provides the technical controls regulated teams rely on: attributable e-signatures, role-based access, and an append-only, hash-chained audit trail. Evidence is captured to ALCOA+ principles and linked to its source requirement. Compliance determination stays with your quality organization; we supply the controls and the documentation to support your assessment.

Eventt AI provides the technical controls regulated teams rely on: attributable e-signatures, role-based access, and an append-only, hash-chained audit trail. Evidence is captured to ALCOA+ principles and linked to its source requirement. Compliance determination stays with your quality organization; we supply the controls and the documentation to support your assessment.

Get started

Audit Trail

GDPR Ready

GDPR Ready

ISO 27001

Tamper-Evident Audit Trail.

Tamper-Evident Audit Trail.

Append-only, hash-chained entries make any later modification detectable.

Attributable E-Signatures

Attributable E-Signatures

Each approval is bound to identity, action, meaning, and timestamp under 21 CFR Part 11.

Role-Based Access Control

Role-Based Access Control

SSO-only authentication with fixed roles scoped per system, including a hard read-only auditor role.

ALCOA+ Evidence Capture

ALCOA+ Evidence Capture

Evidence is captured at execution time, verified against live system state, and hash-anchored.

Insights

Insights

The Anatomy of an Automated Validation.

The Anatomy of an Automated Validation.

How our AI validation engine turned requirements into audit-ready proof.

How our AI validation engine turned requirements into audit-ready proof.

AI Test Generation
Automated Execution
AI Test Generation
Educational

AI Test Generation

Ingest requirements and instantly generate risk-based test scripts.

AI Test Generation
Automated Execution
AI Test Generation
Educational

AI Test Generation

Ingest requirements and instantly generate risk-based test scripts.

AI Test Generation
Automated Execution
AI Test Generation
Educational

AI Test Generation

Ingest requirements and instantly generate risk-based test scripts.

FAQ

FAQ

Clear answers for regulated industries.

Clear answers for regulated industries.

verything you need to know about implementing AI-driven validation and maintaining continuous compliance.

verything you need to know about implementing AI-driven validation and maintaining continuous compliance.

General

Technical & AI

Platform Capabilities

Compliance & Security

Implementation & Support

Does Eventt AI replace my QA or CSV team?

What systems can Eventt AI validate?

How is this different from a validation document-management tool?

General

Technical & AI

Platform Capabilities

Compliance & Security

Implementation & Support

Does Eventt AI replace my QA or CSV team?

What systems can Eventt AI validate?

How is this different from a validation document-management tool?

Ready to trust your systems and prove it?

Ready to trust your systems and prove it?

Stop screenshotting. Start validating. See how Eventt AI handles your most complex workflows.

Stop screenshotting. Start validating. See how Eventt AI handles your most complex workflows.

Book a demo

The trusted standard for software validation in regulated industries. We automate compliance so your experts can focus on quality strategy.

The trusted standard for software validation in regulated industries. We automate compliance so your experts can focus on quality strategy.

© 2026 Eventt AI. All rights reserved.

© 2026 Eventt AI. All rights reserved.

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